Comparison of MBR + Suture Tape, MBR, and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study

NCT05698446 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Third Hospital

Phase

Observational

Started

2021-11-01

Last updated

2025-04-11

Condition(s) studied

Ankle SprainsHypermobility Syndrome

Investigational drug(s) / intervention(s)

Modified Broström + Suture tape augmentation operationAnatomic reconstruction operationOpen Modified Broström procedure

Modified Broström + Suture tape augmentation operation: Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation

Anatomic reconstruction operation: Anatomic reconstruction operation

Open Modified Broström procedure: Open Modified Broström-Gould surgery

Study summary

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years Exclusion Criteria: * Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study

Primary outcome measure(s)

Karlsson-Peterson score — postoperative Karlsson score at 1 year
This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.
Karlsson-Peterson score — postoperative Karlsson score at 2 years
This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.

Trial sites (1)

Facility	City	Region	Status
Peking University Third Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05698446 on ClinicalTrials.gov ↗ ← All trials in China